Casing

ABSTRACT

A casing ( 50 ) for an injection device ( 10 ) of the type having a safety device which prevents operation of the device ( 10 ), incorporating an actuator means ( 56 ) by which the safety means of the device ( 10 ) can be actuated to allow operation of the device ( 10 ). Also a casing ( 50 ) for a medicament container having an opening closed prior to use by a break-off tip ( 135 ), having relatively moveable first and second casing parts ( 51, 52 ), which on relative movement apply a breaking force to the break-off tip ( 135 ). A preferred embodiment includes both such features.

The present invention relates to injection devices, in particular toneedle-less injection devices in which a compressed gas cartridge isused to force a jet of medicament through a patient's skin.Specifically, this invention relates to a casing for such an injectiondevice which interacts with the safety and other mechanisms of such aninjection device.

Injection devices generally comprise a number of elements. Generallythere is a cartridge of a medicament having a nozzle orifice at one end,out of which in the case of a needle-less injection device themedicament is driven under a pressure sufficient to drive it through apatient's skin. Generally there is a drive means to drive the medicamentin this manner, typically comprising a plunger moveable within thecartridge toward the nozzle orifice to drive the medicament, and a meansto drive the plunger, such as a spring, commonly comprising a springmeans such as compressed gas driving a ram which bears upon the plunger.Generally, there is a trigger means operable to cause the drive means toact. Often there is a safety device functioning to prevent the drivemeans from being inadvertently operated. Such a safety means mayfunction in various ways, for example by obstructing the movement of oneor more parts of the injection device which is essential for operationof the device, for example functioning by preventing the trigger meansfrom operating. The cartridge of medicament may for example comprise adose of liquid or powdered medicament to be administered to the patient.Sometimes in a needle-less injection the nozzle orifice of the cartridgeis closed prior to use by a break-off tip. Often the drive means,cartridge is closed prior to use by a break-off tip. Often the drivemeans, cartridge and orifice lie along an elongate direction whichcorresponds to the direction along which the plunger moves and themedicament is dispensed.

Needle-less injection devices of various types are described in, interalia, published International Patent Application Nos. WO-A-93/03779,WO-A-95/03844, WO-A-96/28202 (Weston Medical Limited), U.S. Pat. No.5,865,795 and U.S. Pat. No. 2001/0004681.

Published International Patent Application No. WO-A-97/37705 (WestonMedical Limited), the contents of which are incorporated herein byreference, discloses a needle-less injection device of the general typedescribed above in which compressed gas in a cylinder 130 drives a ram111 which bears upon a plunger 104 which is moveable within a medicamentcartridge 103 to drive medicament content out through orifice 106. Inthe device of WO-A-97/37705 operation of the device is prevented by alatch 108 which obstructs the ram 111 and must be moved sideways toallow the ram 111 to move. A trigger means is provided by the devicecomprising upper 102 a and lower 102 b relatively moveable sleeveportions, and in its pre-firing configuration the sideways movement ofthe latch 108 being obstructed by the wall of the upper sleeve 102 a.The upper 102 a and lower 102 b sleeves are moved relative to each otherby placing the lower sleeve 102 b against the user's skin and urging theupper sleeve downwardly. The relative movement of the upper 102 a andlower 102 b sleeve portions brings an aperture 139 in the wall of theupper sleeve portion 102 a into alignment with the latch 108, allowingthe latch to move sideways into the aperture 139 so that it no longerobstructs the ram. A cam surface 109 on the ram 111 bears on the latch108 under the force exerted by the compressed gas and forces the latchsideways into the aperture 139.

In the device of WO-A-97/37705 a safety mechanism is provided by atear-off band 137 situated between the upper 102 a and lower 102 bsleeve portions functioning to obstruct the said relative movement ofthese sleeve portions until the band 137 has been torn away.

In the device of WO-A-97/37705 the nozzle orifice of the cartridge 103is closed prior to use by a break-off tip 135 which comprises a sealcarrier which carries a seal 134.

However, various problems may arise from the handling and use of adevice such as that of WO-A-97/37705 and similar devices. For instance,the device is fragile and may not be robust enough to be transported bya user in, for instance, a handbag or a pocket. Furthermore, the usermay perform the steps required for the actuation of the device in thewrong order. The device of WO-A-97/37705 must be actuated by firstsnapping off the seal carrier 135 and then removing the tear-off band137, before urging the orifice 106 against the user's skin. If the usermistakenly removes the tear-off band 137 before snapping off the sealcarrier 135, it is possible that the action of snapping off the sealcarrier may cause the device to be inadvertently actuated. This wouldresult in a wasted dose of the medicament and possibly even delivery ofthe medicament into the wrong site (e.g. the user's hand).

Also, once the device has been used, the user must dispose of the deviceand the parts that have been removed, i.e. the seal carrier 135 and thetear-off band 137, in a safe manner so that the user herself or otherpeople, for instance children, are not endangered by loose parts of theactuated device.

Also, in the device of WO-A-97/37705 there is a risk that a weak usermay not be able to apply sufficient force to break the break-off seal135 at the frangible joint 136, or the break-off force may be appliedunevenly e.g. resulting in inadequate opening of the orifice 106.Further once the seal carrier 135 has been broken off the user is leftin possession of the broken-off carrier 135, potentially with sharpedges around the frangible join 136.

An object of the present invention is to provide a casing in which aninjection device, particularly a device such as that of WO-A-97/37705,may be enclosed and which interacts with the device enclosed therein,facilitating the correct operation of the device, and so providing asolution to at least some of the aforementioned problems.

Thus, according to a first aspect the present invention provides acasing for an injection device of the type which comprises a cartridgecontaining a medicament for injection and having an orifice at one endthereof through which the medicament may be driven for injection througha patient's skin, drive means for driving the medicament through thepatient's skin, a trigger means operable to cause the drive means toact, a safety means which in a first configuration prevents the drivemeans from acting and in a second configuration allows the drive meansto act,

wherein

the casing is adapted to enclose the device,

and the casing incorporates an actuator means by which the safety meansof an injection device enclosed therein can be brought from its firstconfiguration into its second configuration.

The casing of the present invention facilitates the use of an injectiondevice, in particular in its preferred embodiments by causing the userto operate the injection device according to its pre-determinedoperating sequence. As secondary advantages the casing can protect theenclosed injection device, improve its aesthetic appearance and improveuser compliance by making the injection device appear less intimidating.

Preferably the actuator means may be accessed by a user from outside thecasing, so that the user can actuate, i.e. bring from its firstconfiguration into its second configuration, the safety means of aninjection device enclosed therein from outside the casing.

In one form for example, the actuator means may have a part exposed tothe outside of the casing and accessible to the user, and to which theuser may apply operating force to actuate the safety means.

For example such an actuating means may be constructed to bear upon thesafety means and thereby apply actuating force to the safety means tobring it from its first configuration into its second configuration.

Herein the term “bear” and derived terms includes all means by which aforce applied to one part is communicated to another part, e.g. bypressing to communicate pressure or pulling to communicate tension.

For example the actuator means may comprise a button, tongue or leverwhich the user may press inwardly to cause the actuator means to bearupon the safety means and thereby bring the safety means from its firstconfiguration into its second configuration.

For example the actuator means, particularly such a button, tongue orlever, may be resiliently connected to the casing such that onapplication of actuating force to the actuator means, the actuator meansoperates against the resilient bias.

For example the actuator means may comprise a means to apply a pullingforce to the safety means to pull the safety means from its firstconfiguration into its second configuration. For example such anactuator means may comprise a slider, slideably moveable relative to thecasing, a connector means connecting the slider to the safety meanswhereby the user can move the slider to pull the safety means from itsfirst configuration into its second configuration. For example such anactuator means may comprise a pulley wheel, rotatably moveable relativeto the casing, a connector means connecting the pulley wheel to thesafety means whereby the user can rotate the pulley wheel to pull thesafety means from its first configuration into its second configuration.

For example the actuator means may be constructed so that after it hasbrought the safety means from its first configuration into its secondconfiguration, the actuator means may give a visible or audible (e.g. a“click”) indication that this has happened. For example the actuatormeans may remain locked in a visibly deflected position.

Preferably the casing has retaining means to retain the safety means ofan enclosed device in its second configuration after the safety meanshas been brought from its first configuration into its secondconfiguration.

In another form, for example the actuator means may comprise a window inthe casing through which the safety means may be actuated. For examplesuch a window may be so shaped and positioned that a user may be able toreach the safety means of an injection device enclosed therein, or sothat a part of or connected to the safety means of an injection deviceenclosed therein may extend through the window to be accessed andoperated by the user from outside of the casing. Such a part maycomprise a pull handle or “ripcord” means which may be pulled fromoutside of the casing to move the safety means from its firstconfiguration into its second configuration.

By “enclosed” is included partial or complete enclosure. As injectiondevices are generally elongate and cylindrical the casing of theinvention will normally be of a generally corresponding shape, e.g. acylinder or ellipsoid in outer shape. Preferably the casing is adaptedto enclose at least the cartridge, the drive means, the trigger meansand the safety means of the injection device. Preferably the casing hasan opening, which may be removably covered prior to use, by which theorifice through which the medicament may be driven for injection througha patient's skin can be brought adjacent to the patient's skin. In anelongate casing such an opening may be an end opening.

Preferably the casing is adapted to enclose the injection device bybeing internally shaped to generally conform to the external shape ofthe device, and/or by the provision of internal supports able tosecurely hold an injection device enclosed therein. The design of thesewill depend upon the shape and construction of the injection device tobe enclosed. If the casing is to hold a device such as that ofWO-A-9737705 which is triggered by being pressed against a user's skin,it is important that the casing is constructed such that pressureapplied to the casing to press the device against the user's skin iscommunicated to the injection device, and such supports may be used toachieve this.

The casing comprises a container for the injection device. The casingmay be of single part construction or of multi-part construction forexample comprising two or more casing sub-parts which fit together byfor example a screw, friction or snap-fit to securely enclose and retainan injection device therein.

A second aspect of the present invention provides a combination of acasing as described above according to the first aspect,

and enclosed within the casing an injection device of the type whichcomprises:

a cartridge containing a medicament for injection and having an orificeat one end thereof through which the medicament may be driven forinjection through a patient's skin, drive means for driving themedicament through the patient's skin, a trigger means operable to causethe drive means to act, a safety means which in a first configurationprevents the drive means from acting and in a second configurationallows the drive means to act.

Such a combination comprises:

an injection device of the type which comprises a cartridge containing amedicament for injection and having an orifice at one end thereofthrough which the medicament may be driven for injection through apatient's skin, drive means for driving the medicament through thepatient's skin, a trigger means operable to cause the drive means toact, a safety means which in a first configuration prevents the drivemeans from acting and in a second configuration allows the drive meansto act;

a casing enclosing the injection device,

wherein the casing incorporates an actuator means by which the safetymeans of the injection device enclosed therein can be brought from itsfirst configuration into its second configuration.

The combination of the casing with the injection device already enclosedtherein may be provided to a user e.g. a prescription patient, as aunit.

Preferably in its first configuration the safety means prevents thedrive means from acting by preventing the trigger means from operating,for example by obstructing the movement of a moveable trigger part, andin its second configuration allows the trigger means to operate.

Therefore preferably the safety means comprises an obstructer part whichin the first configuration obstructs, and in the second configurationallows, the movement of a moveable trigger part.

Such a safety means may be moveable, e.g. by displacement and/ordeformation, by using the actuator means, from its first configurationto its second configuration, e.g. the actuating means may bear upon thesafety means and thereby apply actuating force to the safety means tomove it e.g. by displacement and/or deformation.

When the casing is elongate, preferably a moveable safety meanscomprises an obstructer part which is brought from its firstconfiguration to its second configuration by a movement of theobstructer part e.g. by displacement or deformation, or the entiresafety means, in a direction perpendicular to the elongate direction.

For example a moveable safety means may comprise a collar (the termincludes a part-collar) shaped to at least partly surround the injectiondevice, and moveable from its first configuration into its secondconfiguration in a direction generally perpendicular to the direction inwhich the medicament is dispensed, the collar incorporating anobstructer part.

Preferably the safety means, or at least the obstructer part, is biasedto be retained in its first configuration and is movable against thisbias into its second configuration.

For example a moveable safety means may comprise a removable obstructerpart, e.g. a tear-off band functioning as an obstructer part asdisclosed in WO-A-97/37750, and such a band may have an extension whichis accessible from outside of the casing, e.g. through a window in thecasing, which a user may grip and pull to remove the obstructer partfrom the injection device and from the casing.

Alternatively the safety means may be broken or destroyed in its secondconfiguration, e.g. the actuating means may bear upon the safety meansand thereby apply actuating force to the safety means to break ordestroy it.

Preferably the injection device is as disclosed in WO-A-97/37705 thecontent of which is incorporated herein by reference.

Therefore preferably the trigger means, as in WO-A-97/37705, is providedby two relatively moveable upper and lower sleeve parts which onrelative movement allow the drive means to act.

When the injection device comprises a device in which the trigger meanscomprises two relatively moveable upper and lower sleeve parts which onrelative movement allow the drive means to act, the safety means maycomprise an obstructer part which in its first configuration obstructs,and in its second configuration allows, the relative movement of thesesleeve parts.

For example with such a device preferably the safety means comprises anobstructer part which is brought from its first configuration to itssecond configuration by a movement of the obstructer part in a directionperpendicular to the direction of relative movement of these twosleeves, this direction suitably being perpendicular to the elongatedirection of the device and the casing, being also generallyperpendicular to the dispensing direction of the medicament.

For example when the injection device comprises a device in which thetrigger means comprises two relatively moveable upper and lower sleeveparts which on relative movement allow the drive means to act, as in thedevice of WO-A-9737705, such a moveable safety means may comprise acollar shaped to at least partly surround the injection device, andmoveable from its first configuration into its second configuration in adirection perpendicular to the direction of relative movement of thesetwo sleeves, the collar incorporating an obstructer part which in thefirst configuration is situated between the two sleeves to obstruct therelative movement, and in the second configuration is displaced in adirection perpendicular to the direction of relative movement of thesetwo sleeves to thereby allow the relative movement of these sleeves.

Such a collar may surround that part of the injection device which islongitudinally between the two sleeves. Such a collar may be resilientlybiased into its first configuration, for example by spring parts bearingupon the injection device or upon the casing, so that movement into thesecond configuration is against this bias.

Preferably the safety means, e.g. a collar as described above, hasretaining means by which it may be retained in its second configurationafter the safety means has been actuated. Such retaining means mayinteract, e.g. lock with, corresponding retaining means on the casing orthe injection device. The operation of such retaining means may beaccompanied by a visible or audible indication thereof.

Alternatively the safety means may require a continuous actuation of theactuator means to retain the safety means in its second configuration.

Such a safety means, e.g. the above described collar, may be integrallymade of resilient plastics materials.

A third aspect of the present invention provides a casing adapted toenclose a container of a medicament of the type having an opening at oneend through which the medicament may be accessed for dispensing and theopening being closed prior to use by a break-off tip,

the casing comprising relatively moveable first and second casing parts,being a first casing part adapted to hold the container, and a secondpart adapted to bear upon the break-off tip of a container held by thefirst casing part as a result of such relative motion to apply a forcethereto causing the break-off tip to break off from the container.

Preferably the container is an injection device of the type comprising acartridge having its injection nozzle orifice closed prior to use by abreak-off tip, and the casing comprises a container for the device.

The invention also provides a combination of such a casing and aninjection device enclosed therein.

Such a combination comprises:

a casing enclosing an injection device of the type comprising acartridge having its injection nozzle orifice closed prior to use by abreak-off tip,

the casing comprising relatively moveable first and second casing parts,being a first casing part adapted to hold the injection device, and asecond part adapted to bear upon the break-off tip as a result of suchrelative motion to apply a force thereto causing the break-off tip tobreak off from the injection device.

In one embodiment the first casing part may be elongated along alongitudinal axis, the first casing part may be adapted hold thecontainer non rotatably relative thereto, e.g. by internal supports andthe second part can be moved in rotary motion relative to the first partso as to bear on the break-off tip of a container held by the firstcasing part, and to apply a twisting shearing force to the frangiblejoint between the break-off tip and the container.

Such rotary relative motion may be about a rotation axis coaxial withthis longitudinal axis, about a rotation axis parallel to butnon-coaxial with this longitudinal axis, or about a rotation axis at anon-zero angle to the longitudinal axis. The latter two modes of rotarymotion may be advantageous in applying a shearing force to the frangiblejoint.

For example such rotation may be achieved by means of the first andsecond casing parts being initially connected together by a screw threador bayonet connection, so that un-connecting the connection applies ashear force to break off the tip of a container held by the first casingpart, and also separates the first and second casing parts to herebyexpose the opening for use.

Alternatively such rotary relative motion may be about a rotation axistransverse to e.g. preferably perpendicular to this longitudinal axis soas to snap the frangible joint. For example such rotation may beachieved by the second casing part being pivotally mounted on the firstcasing part, with a pivot axis perpendicular to the longitudinal axis.Alternatively the second casing part may be hinged to the first casingpart about a hinge axis, such that as the second casing part moves inrotary hinged motion about this hinge axis relative to the first casingpart the second casing part bears upon the break-off tip.

Alternatively the second casing part may incorporate a bearing partmoveable relative to the second casing part and first casing part, e.g.operable by a button or lever etc. of the second casing part, to therebybear upon the break off tip.

The second casing part may have internal parts to hold or support thebreak off tip, and/or which bear on the break off tip during therelative motion. The second casing part may be internally provided withgripping means to assist the second casing part in bearing on thebreak-off tip of a container held by the first casing part, and applyingthe shearing force. The design of these will depend upon the shape andconstruction of the injection device to be enclosed.

For example the second casing part may incorporate a cup part havinginternal surfaces of a rubbery material with a high coefficient offriction relative to the break-off tip.

In a preferred embodiment the casing of this third aspect of theinvention is a casing of the first aspect of the invention, which may beused in a combination as in the second aspect of this invention, and thefirst casing part is adapted to hold an injection device wherein thecartridge has an opening at one end through which the medicament may bedispensed and the opening is closed prior to use by the break-off tip.

This preferred embodiment of the invention therefore comprises;

a casing for an injection device of the type which comprises a cartridgecontaining a medicament for injection and having an orifice at one endthereof through which the medicament may be driven for injection througha patient's skin, drive means for driving the medicament through thepatient's skin, a trigger means operable to cause the drive means toact, a safety means which in a first configuration prevents the drivemeans from acting and in a second configuration allows the drive meansto act, and having its injection nozzle orifice closed prior to use by abreak-off tip, wherein:

the casing is adapted to enclose the device,

and the casing incorporates an actuator means by which the safety meansof an injection device enclosed therein can be brought from its firstconfiguration into its second configuration, and,

the casing comprises relatively moveable first and second casing parts,being a first casing part adapted to hold the injection device, and asecond part adapted to bear upon the break-off tip as a result of suchrelative motion to apply a force thereto causing the break-off tip tobreak off from an injection device enclosed within the casing.

Preferably for use with such an injection device the first casing partmay be elongated in the longitudinal direction along which the plungermoves to drive the medicament through the orifice.

Preferably when the first casing part is adapted to hold an injectiondevice the first casing part has an opening by which the orifice throughwhich the medicament may be driven for injection through a patient'sskin can be brought adjacent to the patient's skin, and this opening maybe an end opening of an elongate first casing part, and the secondcasing part comprises a removable cover for this end opening, e.g. inthe form of an end cap.

In this preferred embodiment, the casing may be constructed so that theactuator means cannot be operated before the second casing part has beenmoved relative to the first casing part in the manner described above.This can ensure that an injection device contained therein is operatedin the correct operating sequence, i.e. the break-off tip is firstbroken off and only thereafter the drive means can be caused to operate.

For example the second casing part may comprise a cover part over theactuator means which prevents operation of the actuator means until thecover part is removed. For example the second casing part may comprise acap, covering the actuator, with a screw thread connection to the firstcasing part and the action of unscrewing such a cap may both break offthe break-off tip and expose the actuator for use.

Alternatively the second casing part may incorporate a locking means tolock the actuator means until the second casing part has been removed.

Alternatively the second casing part may comprise the actuator means, sothat the movement of the second casing part relative to the first casingpart causes the safety means of an injection device enclosed within thecasing to move from its first configuration to its second configuration.For example the second casing part may comprise a bearing part whichbears upon the safety means, e.g. by pressure or pulling analogous tothe description above, to move the safety means from its firstconfiguration to its second configuration.

For example the second casing part may itself comprise a safety means.For example the second casing means may incorporate at least oneobstructer part which functions to obstruct movement of a part of theinjection device which is essential for operation, and which is movedfrom a first configuration to a second configuration by the relativemovement of the second casing part.

The casing of all aspects of the invention, and the safety means such asa collar, may conveniently be made of plastics materials by for exampleinjection moulding.

The invention also provides a combination of such a casing and aninjection device enclosed therein.

Preferred features of such a casing, and its combination with aninjection device, are as described above.

The construction and operation of a device according to this inventionwill now be described by way of example only with reference to thefollowing Figures.

FIGS. 1-4 show schematically the operation of a known type ofneedle-less injection device.

FIGS. 5-8 show schematically the construction of a casing of thisinvention and its operation with a device as shown in FIGS. 1-4.

FIG. 9 shows the construction and operation of the safety means as usedin the casing of FIGS. 1 to 8.

FIGS. 10 and 11 show schematically the construction of another casing ofthis invention and its operation with a device as shown in FIGS. 1-4.

FIGS. 12 and 13 show schematically the construction of another casing ofthis invention and its operation with a device as shown in FIGS. 1-4.

FIGS. 14 and 15 show schematically the construction of another casing ofthis invention and its operation with a device as shown in FIGS. 1-4.

FIGS. 16 and 17 show schematically the construction of another casing ofthis invention and its operation with a device as shown in FIGS. 1-4.

FIG. 18 shows a casing of this invention, in multi-part construction.

Referring to FIGS. 1-4 the operation of the device 10 disclosed inWO-A-97/37705 is illustrated schematically, the numbering scheme ofWO-A-97/37705 being followed in these drawings. The device 10 comprisesan upper sleeve part 102 a and a lower sleeve part 102 b which arerelatively moveable toward each other. At the lower end of the device isa break-off tip 135 which can be broken off at frangible joint 136 asdescribed in WO-A-97/37705 to open a nozzle orifice 106. The action ofmoving the sleeve parts 102 a, 102 b in the way described triggers thelatch mechanism (108 in WO-A-97/37705, not shown in FIGS. 1-4) andcauses compressed gas in cylinder 130 to operate an internal ram (111 inWO-A-97/37705, not shown in FIGS. 1-4) which drives medicament content105 in cartridge 103 out through orifice 106. However prior to use therelative movement of sleeve parts 102 a and 102 b is obstructed bytear-off band 137, being a safety means.

The operation of the device is shown sequentially through FIGS. 1-4.FIG. 1 shows the pre-use configuration with band 137 in place. In FIG. 2the break-off tip 135 has been broken off at frangible joint 136,exposing orifice 106. In FIG. 3 the tear off band 137 has been tom offso that relative movement of sleeve parts 102 a, 102 b is no longerobstructed. In FIG. 4 the orifice 106 has been placed against the skin11 of the user and pressure has been applied to the cylinder 130 toforce sleeve part 102 a downwardly relative to sleeve part 102 b. Asdescribed in WO-A-97/37705 this has “fired” the device and caused themedicament 105 to be injected through the user's skin 11.

Referring to FIGS. 5-9 a casing 50 of this invention is shown in alongitudinal sectional view. The casing 50 encloses a device 10 as shownin FIGS. 1-4. The device 10 is an elongate device, the direction of itslongitudinal axis being shown by a dashed line. This direction is alsothe direction along which the sleeve parts 102 a, 102 b move relative toeach other, and the direction in which medicament content is ejectedfrom the orifice 106.

The casing 50 is generally ellipsoidal elongate in a direction parallelto the longitudinal axis of the device 10 and comprises a first casingpart 51 and a second casing part 52. The first casing part 51 and secondcasing part 52 are joined at a screw thread connection 53. Each casingpart 51, 52 may itself comprise sub-assemblies fitted together. Thecasing parts 51, 52 are made of plastics material by injection moulding.

Within first casing part 51 the device 10 is supported and held securelyby internal supports, bulkheads etc. (not shown but the construction ofwhich will be apparent to those skilled in the art). In particular thedevice 10 is held within first casing part 51 such that device 10 isnon-rotatable relative to part 51 about an axis parallel to the longaxis of casing 51, 52.

The tear-off band 137 shown in FIGS. 1-4 is not present on the device10. In its place is a safety means 54 comprising a collar which fitsaround the cartridge 103 and the sleeve parts 102 a, 102 b. Theconstruction of part 54 is shown in more detail in FIG. 9. As seen inFIG. 9A being a cross section through the collar 54 and device 10 atline A-A in FIG. 5, and FIG. 9B being a longitudinal part sectional viewthrough the collar 54 and immediately adjacent part of device 10, atright angles to the line A-A of FIG. 9A, the part 54 comprises a collar541 of cross sectional dimensions greater than that of sleeve parts ofsleeve parts 102 a, 102 b. The part 54 has an obstructer part 542 beinga block which when the part 54 is in place around the cartridge 103 asshown in FIG. 5 obstructs any relative longitudinal movement of sleeves102 a and 102 b, by fitting longitudinally between them and blockingtheir relative movement. The collar 541 is supported in thisconfiguration by resilient spring leaves 543, 544 which bear on thesleeve parts 102 a, 102 b. This is the first configuration of part 54.

Referring to FIG. 6 the second casing part 52 has been rotated relativeto the first casing part 51 about the axis of rotation R, therebyunscrewing second casing part 52 from first casing part 51 at screwconnection 53 and disconnecting parts 51 and 52. Second casing part 52has internal parts e.g. internal supports, walls etc. (not shown but theconstruction of which will be apparent), which bear upon the break-offtip 135. Axis R is parallel to but no co-axial with the longitudinalaxis of the part 10, a shearing force is applied to the frangible joint136, which consequently breaks. The device 10, is now in a configurationcorresponding to FIG. 2.

Referring to FIG. 7 an actuator means is provided by a resilient tongue55, integral with first casing part 51, and which can be inwardlydeflected by pressure on an operating button 56. This inward deflectioncauses button 56 to bear upon the upper surface (as seen in FIG. 9) ofthe collar 541, and the collar 541 to be consequently moved downwardlyagainst the resilience of springs 543, and the obstructer part 542 to beconsequently moved into a position in which it does not obstruct therelative movement of sleeve parts 102 a and 102 b. This is shown moreclearly in FIG. 9C, being the second configuration of part 54. When inthis second configuration the first casing part 51 and part 54 may haveco-operating means, e.g. snap fit detent means, so that part 54 isretained in this second configuration independently of pressure appliedby button 56. Alternatively, e.g. as a further safety feature, thecasing may be constructed so that continued pressure on part 55 isnecessary to hold part 54 in this second configuration. The device 10 isnow in a configuration corresponding to FIG. 3.

Also as shown in FIGS. 5 and 6, the second casing part 52 integrallyincorporates a cover part 57 comprising a cover flap which covers theactuator button 56 when the second casing part is attached by the screwthread 53 to first casing part 51. This prevents the actuator part 56from being actuated in the manner shown in FIG. 7 until the secondcasing part 52 has been unscrewed from first casing part 51 and removedin the downward direction as shown, with the consequence of breaking offthe break off tip 135, and thereby causes the user to operate the device10 in the proper operating sequence as described with reference to FIGS.1-4.

Referring to FIG. 8, the orifice 106 has been placed against the skin 11of the user and pressure has been applied to the first casing part 51 inthe direction toward the skin 11. Tis pressure is communicated to theinjection device 10 to force sleeve part 102 a downwardly relative tosleeve part 102 b. In a manner corresponding to FIG. 4 this has causedthe device 10 to “fire” and to inject medicament 105 through the user'sskin 11.

Referring to FIG. 10, another casing 110 of this invention is shown in aside view. The casing 100 incorporates a device 10 as with the casing ofFIGS. 5-9. The casing 100 comprises first casing part 111 and secondcasing part 112. The internal construction of the first casing part 111is analogous to that of first casing part 51, i.e. incorporating asafety means 54 and an actuating means 55, 56 as therein.

FIG. 11 shows a plan view of the casing 110 illustrating more clearlythe construction of the part 55 and 56, which is analogous to those ofFIGS. 5-9.

In the casing 110 the second casing part 112 is mounted on two oppositepivot axles 113, so that part 112 can rotate about the axis betweenthese axles 113, this axis of rotation being perpendicular to thelongitudinal axis of the device 10 and of the elongated casing 110, sothat part 112 swings in rotation relative to part 111 and follows thearc shown in FIG. 10, to swing into the position shown in FIG. 11A. Asthe casing part 112 rotates in this way its internal parts (not shown),such as internal ribs or a cup-shaped holder to hold the break-off tip135, bear upon the break-off tip 135 and cause the frangible joint 137to shear analogously to FIGS. 2 and 6. As the part 112 continues torotate along this arc, it carries the broken off tip 135 away fromorifice 106. The casing parts 111, 112 may have respective co-operatinglocking means (not shown) by which the part 112 may be initiallyreleasably locked in place in its non-rotated configuration as shown inFIG. 10 before being unlocked to allow the casing part 112 to swingthrough the arc. Such a locking means may help to prevent accidentalbreak-off of the break off tip 135.

The actuator button 56 can then be operated in a manner analogous to thecasing of FIGS. 5-9 to render the device 10 ready to trigger andoperate.

The orifice 106 can then be placed against the user's skin 11 in amanner analogous to FIG. 8 and pressure can be applied to the firstcasing part 111 to force sleeve part 102 a downwardly relative to sleevepart 102 b causing the device 10 to “fire” as in FIGS. 4 and 8 to injectmedicament 105 through the user's skin 11.

In the device of FIGS. 10 and 11 it is of course important that the arcwhich the second casing part 112 follows allows sufficient of the device10 to project beyond the lower end as shown of the casing part 111 toallow the orifice 106 to be placed adjacent to the user's skin. This canbe arranged by a suitable geometry of the casing 110 to give the secondcasing part 112 sufficient clearance of the orifice 106 as the part 112swings in its arc. The second casing part 112 may also be constructed sothat a downward (as shown) movement of the second casing part 112 isnecessary before the second casing part 112 can pivot in the mannershown. This can be achieved for example by means of a “keyhole” shapedpivot socket which engages with an elongate section stub axle which canonly rotate when the axle has been moved longitudinally into the widepart of the “keyhole”. This can help to provide the clearance betweenthe second casing part 112 and the orifice 106.

The dimensions of the casing parts 111 and 112 may be such that thesecond casing part 112 may rotate through 180° from the position shownin FIGS. 10 and 11 so that it can conveniently be “stowed” at theopposite end of the first casing part 111 to that from which the orifice106 projects.

It will be apparent that the casing 51, 52, 101, 102 facilitates theoperation of the device 10, and as seen in FIG. 11 can enhance theoutward appearance of the casing.

Referring to FIGS. 12 and 13 another casing 120 is shown in schematiclongitudinal section. The casing 120 is similar in construction to thatof FIGS. 5-8, having a first casing part 121, and a second casing part(not shown) which is identical to that 52 of FIGS. 5-8 and which isinitially connected to casing part 121 by a screw thread in an analogousmanner. In FIG. 12 the casing 120 is shown with this second casing partremoved, i.e. in a configuration analogous to FIG. 7.

The casing 120 incorporates a device 10 as shown in FIGS. 1-4. Thedevice 10 has a safety means being a tear-off band 137 analogous to thatshown in FIGS. 1 and 2. The band 137 has an extension 122 which extendsthrough a window aperture 123 in first casing part 121 to the outside ofcasing part 121. The extension 122 may be gripped by a user and pulledfrom outside the casing to thereby remove the band 137 as seen in FIG.13. The casing 120 is then in a configuration analogous to FIG. 7 andmay be used in a manner analogous to FIG. 8. It will be appreciated thatband 137 in FIG. 12 may be replaced by other forms of removableobstructer means. As in FIGS. 5-8 a cover part such as that 57 may coverthe extension 122 until the second casing part has been removed.

Referring to FIGS. 14 and 15, these illustrate casings 140, 150 similarin general concept to FIGS. 12 and 13, and corresponding parts arenumbered correspondingly, but in which the actuator means may comprise ameans to apply a pulling force to the safety means to pull the safetymeans from its first configuration into its second configuration.

In FIG. 14 the actuator means 141 comprises a slider 141 e.g. in theform of a slider button, easy for the user to access and use, slideablymoveable relative to the casing 140. For example the slider may bemounted in a slide groove or track (not shown) in the wall of the casing140. The slider 141 is connected e.g. integrally to a connector means142 connecting the slider 141 to the safety means 137. The user can movethe slider 141 to pull the safety means 137, and this can cause thesafety means to be pulled from its first configuration (as shown in FIG.14) into its second configuration e.g. analogous to FIG. 13. For examplethe safety means 137 may comprise a plastics material strip which can beunwound from its position around the device 10.

In FIG. 15 the actuator means 151 comprises a pulley wheel, rotatablymoveable e.g. by being mounted on an axle (not shown) relative to thecasing 150 and which can easily be rotated by the user, e.g. by a thumboperation. There is a connector means 152 connecting the pulley wheel151, e.g. an integral construction, to the safety means 137 whereby theuser can rotate the pulley wheel 151 to pull the safety means from itsfirst configuration (as shown in FIG. 15) into its second configuratione.g. analogous to FIGS. 1-4.

Referring to FIGS. 16 and 17, these illustrate casings similar inconcept to FIGS. 10-11 and FIGS. 5-8, corresponding parts of which arenumbered correspondingly, but in which the second casing part 163 or 172comprises the actuator means 161, or safety means 171, so that themovement of the second casing part 163 or 172 relative to the firstcasing part 111, 51 causes the safety means 162, 171 of an injectordevice 10 enclosed within the casing 160, 170 to move from its firstconfiguration to its second configuration.

In FIG. 16 the second casing part 163 comprises a bearing part 161 inthe form of plastics connector strip 161 which may be integrally madewith the tear-off band 162 which comprises a safety means analogous inoperation to that 137 of FIG. 12. When the second casing part 163 isrotated to unscrew casing part 163 from first casing part 51, thebearing part 161 bears upon the safety means 162 by pulling the safetymeans 162 and unwinding safety means 162 from the device 10 enclosedtherein, as shown in FIG. 16A. Consequently the break-off tip 135 isfirst broken off as second casing part 163 rotates, then the safetymeans 162 functions to allow the trigger of the device 10 to operate ina manner analogous to that above.

In FIG. 17 the second casing part 172 itself comprises a safety means.The second casing part 172 incorporates at least one obstructer part171, projecting inwardly toward the device 10 enclosed therein. In itsfirst configuration as shown in FIG. 17 the obstructer part 171functions to obstruct relative movement of the trigger parts 102 a, 102b of the device 10 as shown in FIGS. 1-4. As second casing part 172swings in an arc about the pivot axis 113, the second casing part 172firstly breaks off the break-off tip in a manner analogous to FIGS. 10and 11, and then as second casing obstructer part 171 moves out of itsobstructing position between the upper sleeve part 102 a, and lowersleeve part 102 b. The first casing part 170 may be made with suitableclearances etc. to allow the movement of the obstructer part 171.

Referring to FIG. 18, a casing 180 is shown in a dissembled view. Thecasing 180 is generally similar in construction and operation to thatshown in FIGS. 5-8 as will be apparent.

Referring to FIG. 18 a casing 180 of this invention is shown in alongitudinal sectional view. The casing 180 is of multi-partconstruction for example comprising a first casing sub-part 181 and asecond casing sub-art 182 which fit together by a tight friction orsnap-fit fit of plug part 1811 of part 181. When fitted together theparts 181 and 182 define an elongate casing which can enclose aninjection device (not shown) of the general type 10 described above,with its break-off tip 135 projecting through an end opening 183 of part182. The casing sub-parts 181, 182 are shaped internally and areprovided with internal support ribs 184 to hold the device 10non-rotatably within the assembled casing 181, 182. Internally the part182 has a conical interior at 185. The device 10 has a correspondingconical outer profile which can abut against this internal conicalprofile 185, and there is also an end support 186 against which a device10 within the casing assembly 181, 182 can abut, and these featuresprevent longitudinal movements of the device 10.

Casing sub-part 182 incorporates an actuator means 187, 177 similar inconstruction to that 56, 57 of FIG. 7. The actuator means comprises aresilient tongue 187, integral with sub-part 182, an which can beinwardly deflected by pressure on an operating button 188.

Located within sub-part 182 is a collar 189, similar in overallconstruction to that described with references to FIG. 9. Collar 189 isshown in a longitudinal view in FIG. 18A and in perspective view in FIG.18B. Corresponding to FIG. 9 the collar 189 comprises an obstructer part1891 and resilient spring leaves 1892. The operation of the collar 189under the action of the actuator means 187, 188 is analogous to collar541 of FIG. 9. However as an additional feature the sub-part 182 isprovided with a cut out 190 into which the obstructer part 1891 may fitwhen the collar 189 is displaced in the downward direction as seen, sothat the obstructer part 1891 can be seen therein as a confirmation thatthe device has been properly operated.

The casing assembly 181, 182 comprises a first casing part. The casing180 also has a second casing part 200, in the form of a generallyrounded conical cover into which the sub-part 182 fits and engages bymeans of co-operating screw threads 201, 202. The casing part 200 has anose cone 203 which is made of a high-friction elastomer material whichcan grip the break-off tip 135 of a device 10 enclosed in first casing181, 182, the nose cone 203 being shaped internally concave so that thebreak off tip 135 can comfortably fit into the conforming concavity 204.

In a construction and operation analogous to FIGS. 5 and 6, the secondcasing part 200 can be rotated relative to first casing part 181, 182,about an axis of rotation thereby unscrewing second casing part 200 fromfirst casing sub-part 182 at screw connection 201, 202, therebydisconnecting parts 181, 182 from second casing part 200. Second casingpart 200 is constructed such that the concavity 204 is not concentricwith the axis of rotation, so that as second casing part 200 rotatesabout this axis the nose cone 203 is displaced transverse to therotation axis and bears upon the break-off tip 135. A shearing force isconsequently applied to the frangible joint 136, which consequentlybreaks, in a manner analogous to FIG. 6.

The second casing part 200 is also constructed so that as it fits oversub-part 182, casing part 200 covers actuator means 187, 188 so that theactuator means 187, 188 is shielded from being actuated until casingpart 200 has been unscrewed and removed, thereby first breaking off thebreak-off tip 135 and therefore causing device 10 to be operated in thecorrect operating sequence.

1. A needleless injection device, comprising a casing; a cartridgecontaining a medicament for injection and an orifice at one end thereofthrough which the medicament is driven for injection through a patient'sskin; a drive mechanism which upon actuation applies force to themedicament, forcing the medicament out of the orifice and through thepatient's skin; a trigger mechanism which actuates the drive mechanism;a safety mechanism which, in a first configuration, prevents the triggermechanism from actuating the drive mechanism and in a secondconfiguration allows trigger mechanism to actuate the drive mechanism;and an actuator lever which moves the safety mechanism from its firstconfiguration into its second configuration; wherein the actuator levercomprises a portion extending outside of the casing which portion isaccessible to a user and which portion is comprised of a componentconfigured such that when the portion is moved by the user the componentapplies a pulling force to the safety mechanism to pull the safetymechanism into its second configuration.
 2. The device of claim 1,wherein the safety mechanism in its first configuration prevents thetrigger mechanism from moving.
 3. The device of claim 1, furthercomprising: a retaining mechanism which retains the safety mechanism ofan enclosed injection device in its second configuration after thesafety mechanism has been brought into its second configuration.
 4. Thedevice of claim 2, wherein the safety mechanism comprises an obstructerportion which in the first configuration obstructs, and in the secondconfiguration allows, movement of the trigger mechanism.
 5. The deviceof claim 4, wherein the safety mechanism comprises a collar shaped tosurround a portion of the injection device, the collar is moveable fromits first collar configuration into its second collar configuration in adirection generally perpendicular to a direction in which the medicamentexits the orifice, the collar comprising an obstructer portion.
 6. Thedevice of claim 5, wherein the trigger mechanism is comprised of twomoveable upper and lower sleeve portions which on relative movementallow the drive mechanism to act, and the safety mechanism comprises anobstructer portion which in its first configuration obstructs, and inits second configuration allows, the relative movement of the sleeveportions.
 7. The device of claim 6, wherein the safety mechanismcomprises an obstructer portion which is brought from its firstconfiguration to its second configuration by a movement of theobstructer portion in a direction perpendicular to a direction ofrelative movement of the two sleeve portions.
 8. A combinationcomprising: a casing which partially encloses a needleless injectiondevice; wherein the needleless injection device comprises: a cartridgecontaining a medicament for injection and an orifice at one end thereofthrough which the medicament is driven for injection through a patient'sskin; a drive mechanism which upon actuation applies force to themedicament, forcing the medicament out of the orifice and through thepatient's skin; a trigger mechanism which actuates the drive mechanism;a safety mechanism which, in a first configuration, prevents the triggermechanism from actuating the drive mechanism, and, in a secondconfiguration, allows the trigger mechanism to actuate the drivemechanism; and a break-off tip which encloses the cartridge orificeprior to being broken off, the break-off tip configured such thatbreaking off the break-off tip irreversibly exposes an actuator for thesafety mechanism.
 9. The combination of claim 8, wherein the casing maybe broken off to provide for sequential operation of the needlelessinjection device.
 10. The combination of claim 9, wherein the sequentialoperation provides for (a) breaking off the break-off tip; and (b)placing the safety mechanism in the second position.
 11. The combinationof claim 10, wherein the casing comprises moveable first and secondcasing components, a first casing component adapted to hold theinjection device, and a second casing component adapted to bear upon thebreak-off tip as a result of relative motion of the first and secondcomponents to apply a force thereto causing the break-off tip to breakoff from an injection device enclosed within the casing.
 12. Thecombination of claim 11, wherein the first casing component is elongatedwith an opening at a first end.
 13. The combination of claim 12, whereinthe first casing component is elongated along a longitudinal axis, andwherein the second casing component is designed to apply a rotary motionrelative to the first portion so as to bear on the break-off tip of acontainer held by the first casing portion, and to apply a twistingshearing force to the frangible joint between the break-off tip and thecontainer.
 14. The combination of claim 13, wherein the rotary motion ischosen from: transverse to the longitudinal axis; perpendicular to thislongitudinal axis; coaxial with the longitudinal axis; about a rotationaxis parallel to but non-coaxial with this longitudinal axis; about arotation axis at a non-zero angle to the longitudinal axis.
 15. Thecombination of claim 14, wherein the rotary motion is about a rotationaxis at a non-zero angle to the longitudinal axis.
 16. The combinationof claim 11, wherein the second casing component comprises a coverportion over the actuator for the safety mechanism which preventsoperation of the actuator for the safety mechanism until the coverportion is removed.
 17. The combination of claim 9, wherein the actuatorfor the safety mechanism moves the safety mechanism from its firstconfiguration to its second configuration.
 18. The combination of claim17, wherein the actuator moves the safety mechanism from its firstconfiguration to its second configuration by pulling.
 19. Thecombination of claim 18, wherein the safety mechanism comprises anobstructer portion which functions to obstruct movement of a portion ofthe injection device which is essential for operation.
 20. The injectiondevice of claim 1, wherein the drive mechanism comprises a compressedgas cylinder.
 21. The combination of claim 8, wherein the casingcomprises a first casing sub-part and a second casing sub-part which fittogether by a method chosen from, a tight friction fit, and a snap-fitfit.
 22. A needleless injector device, comprising: a cartridgecontaining a medicament for injection and an orifice at one end thereofthrough which the medicament is driven for injection through a patient'sskin; a drive mechanism which upon actuation applies force to themedicament, forcing the medicament out of the orifice and through thepatient's skin; a trigger mechanism which actuates the drive mechanism;a safety mechanism which in a first configuration prevents movement ofthe trigger mechanism and in a second configuration allows movement ofthe trigger mechanism; and a casing which encloses the drive mechanism,the casing comprising a break-off tip configured such that breaking offthe break-off tip irreversibly exposes both the safety mechanism and theorifice through which the medicament is driven for injection through apatient's skin.
 23. A needleless injection device, comprising a casing;a cartridge containing a medicament for injection and an orifice at oneend thereof through which the medicament is driven for injection througha patient's skin; a drive mechanism which upon actuation applies forceto the medicament, forcing the medicament out of the orifice and throughthe patient's skin; a trigger mechanism which actuates the drivemechanism; a safety mechanism which, in a first configuration, preventsthe trigger mechanism from actuating the drive mechanism and in a secondconfiguration allows the trigger mechanism to actuate the drivemechanism; a retaining mechanism which retains the safety mechanism ofan enclosed injection device in its second configuration after thesafety mechanism has been brought into its second configuration; and anactuator lever which moves the safety mechanism from its firstconfiguration into its second configuration; wherein the actuator levercomprises a portion extending outside of the casing which portion isaccessible to a user and which when the portion is moved by the user themovement brings the safety mechanism into its second configuration. 24.The device of claim 23, wherein the safety mechanism in its firstconfiguration prevents the trigger mechanism from moving.
 25. The deviceof claim 23, wherein the actuator lever is comprised of a componentwhich applies a pulling force to the safety mechanism to pull the safetymechanism from its first configuration into its second configuration.26. The device of claim 25, wherein the safety mechanism comprises anobstructer portion which in the first configuration obstructs, and inthe second configuration allows, movement of the trigger mechanism. 27.The device of claim 26, wherein the safety mechanism comprises a collarshaped to surround a portion of the injection device, the collar ismoveable from its first collar configuration into its second collarconfiguration in a direction generally perpendicular to a direction inwhich the medicament exits the orifice, the collar comprising anobstructer portion.
 28. The device of claim 27, wherein the triggermechanism is comprised of two moveable upper and lower sleeve portionswhich on relative movement allow the drive mechanism to act, and thesafety mechanism comprises an obstructer portion which in its firstconfiguration obstructs, and in its second configuration allows, therelative movement of the sleeve portions.
 29. The device of claim 28,wherein the safety mechanism comprises an obstructer portion which isbrought from its first configuration to its second configuration by amovement of the obstructer portion in a direction perpendicular to adirection of relative movement of the two sleeve portions.